Apical Periodontitis and Mental Health

NCT06589076 | Completed

• 1 other identifier: MHAP001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the relationship between anxiety, depression and apical periodontitis (AP), a common oral inflammatory condition. The research is being conducted at the Unit of Endodontic and Conservative Dentistry, University of Siena, Italy, with participants aged over 18. Participants are divided into two groups: those with apical periodontitis and those without. The study aims to determine whether there is an association between anxiety, depression (assessed using the Hamilton Anxiety/Depression Rating Scale), and the presence or severity of apical periodontitis. Data collection includes dental exams, radiographs, and anxiety and depression assessments. This research may help to better understand how mental health and dental health are connected.

Conditions

Apical Periodontitis; Anxiety; Depression

Keywords

Oral Health; Mental Health; Apical Periodontitis; Anxiety; depression; smokers

Outcome Measures

Primary Outcomes (3)

• Hamilton Anxiety Rating Scale (HAM-A) Score

  The severity of anxiety symptoms is measured using the Hamilton Anxiety Rating Scale (HAM-A). This scale assesses both psychological (mental distress) and somatic (physical symptoms) aspects of anxiety. Scores range from 0 to 56, with higher scores indicating more severe anxiety. The association between HAM-A scores and the presence of apical periodontitis (AP) will be analyzed.

  At baseline (during participant enrollment and evaluation)

• Hamilton Depression Rating Scale (HAM-D) Score

  The severity of depression is assessed using the 17-item Hamilton Depression Rating Scale (HAM-D). The scale evaluates a range of depressive symptoms such as mood disturbances, guilt, insomnia, anxiety, and somatic concerns. Scores range from 0 to 52, with higher scores indicating more severe depression. The association between HAM-D scores and the presence of apical periodontitis (AP) will be analyzed.

  At baseline (during participant enrollment and evaluation)

• Periapical Index (PAI) Score

  The Periapical Index (PAI) score is used to assess the severity of apical periodontitis. The score ranges from 1 to 5, with higher scores indicating more severe periapical inflammation. The association between PAI scores and anxiety (HAM-A) and depression (HAM-D) scores will be analyzed.

  At baseline (during participant enrollment and evaluation)

Secondary Outcomes (2)

• Decayed, Missing, and Filled Teeth (DMFT) Index

  At baseline (during participant enrollment and evaluation)

• Smoking Status and Its Association with Mental Health and Oral Health

  At baseline (during participant enrollment and evaluation)

Study Arms (2)

Case Group (AP+):

This group consists of participants who have apical periodontitis (AP), an oral inflammatory condition. These participants are diagnosed with AP based on radiographic evidence. They may exhibit symptoms of AP, but AP is often asymptomatic, so radiographic confirmation is key.

Diagnostic Test: Clinical and Radiographic assessment + Questionnaires

Control Group (AP-):

This group consists of participants who do not have apical periodontitis (AP). These participants are healthy individuals with no clinical or radiographic signs of apical periodontitis. They will be matched with the case group based on age, gender, and other relevant characteristics, but they will not have any dental lesions related to apical periodontitis.

Diagnostic Test: Clinical and Radiographic assessment + Questionnaires

Interventions

Clinical and Radiographic assessment + Questionnaires DIAGNOSTIC_TEST

* Clinical and radiographic examination to assess oral health and apical periodontitis. * Questionnaires to assess Anxiety and depression.

Case Group (AP+):; Control Group (AP-):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants fulfilling the previously described inclusion criteria will be allocated into two distinct groups based on the presence or absence of apical periodontitis (AP). Group 1 will consist of 36 patients showing radiographic signs of apical periodontitis (AP+), while Group 2 will include 35 healthy individuals (AP-) with no clinical or radiographic evidence of AP, serving as controls. Participants in both groups will be matched based on age, sex, and other relevant characteristics. AP cases will be defined as patients with at least one tooth exhibiting radiographic evidence of apical radiolucency, graded using Peri Apical Index (PAI) Score.

You may qualify if:

• Ability and willingness to give written consent;
• Age above 18 years old;
• Presence of an untreated periapical lesion for the case group;
• Absence of a periapical lesion for the control group.

You may not qualify if:

• Diabetes;
• Rheumatoid Arthritis;
• Use of corticosteroid drugs;
• Stage 3 and 4 of periodontitis;
• Inability or unwillingness to give informed consent.

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Senese

Siena, Tuscany, 53100, Italy

Location

MeSH Terms

Conditions

Periapical Periodontitis; Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Simone Grandini, PhD, DDS

  University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professore

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: April 13, 2026

Record last verified: 2022-01

Locations

IT (1)